CLASS III Drug recall · Reported 26 Feb 2020 · FDA Enforcement Report
Memantine Hydrochloride Extended-release Capsules, 28mg recalled
The Harvard Drug Group is recalling Memantine Hydrochloride Extended-release Capsules, 28mg, distributed nationwide in the US. The recall was initiated on 13 Dec 2019 and the FDA has classified it as Class III.
Check your package
Check the lot number on your package against the affected lots. If it matches, contact the pharmacy that dispensed it or your prescriber before stopping any medication.
Recall details
- Recall number
- D-0844-2020
- FDA event ID
- 84955
- Recalling firm
- The Harvard Drug Group, Livonia, MI
- Manufacturer
- Major Pharmaceuticals
- Classification
- Class III
- Status
- Terminated
- Recall initiated
- 13 Dec 2019
- FDA classified
- 14 Feb 2020
- Reported
- 26 Feb 2020
- Type
- Voluntary: Firm initiated
- Customers notified by
- Letter
- Reason category
- Potency & Assay
Timeline
| 13 Dec 2019 | Recall initiated by company | |
| 14 Feb 2020 | Classified by FDA | +63 days |
| 26 Feb 2020 | Published in enforcement report | +12 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
Reason for recall
Failed Dissolution Specifications: High out of specification result observed at stability studies.
Potency and specification recalls happen when a batch tests outside its approved limits for strength, purity or dissolution, which can mean the dose delivered is higher or lower than labelled.
Product as listed by the FDA
Memantine Hydrochloride Extended-release Capsules, 28mg, packaged in 100-count Unit Dose Cartons , Rx only, Manufactured for: Lupin Pharmaceuticals, Inc., Baltimore, Maryland 21202 United States; Distributed by: Major Pharmaceuticals, 17177 N Laurel Park Dr., Suite 233, Livonia, MI 48152 USA, NDC 0904-6735-61
Where it was distributed
U.S.A. Nationwide
Questions about this recall
Is Memantine Hydrochloride Extended-release Capsules, 28mg recalled?
Yes. The Harvard Drug Group recalled Memantine Hydrochloride Extended-release Capsules, 28mg on 13 Dec 2019. The recall is Class III and its status is Terminated. Recall number D-0844-2020.
Why was it recalled?
Failed Dissolution Specifications: High out of specification result observed at stability studies.
Which lots are affected?
Lot# M02465D
Where was it sold?
U.S.A. Nationwide
What should I do if I have it?
Check the lot number on your package against the affected lots. If it matches, contact the pharmacy that dispensed it or your prescriber before stopping any medication.
What does Class III mean?
Class III recalls are for products unlikely to cause any adverse health consequence, usually labelling or quality issues.
Read the official FDA notice · Source record retrieved 21 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.
More recalls from The Harvard Drug Group
All 79| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Drug | CLASS II | Carton Label: Major, Methylergonovine Maleate Tablets recalledMethylergonovine Maleate | The Harvard Drug Group | Potency & Assay | Nationwide |
| Drug | CLASS II | Omega-3-Acid, Ethyl Esters, Capsules recalled by The Harvard Drug GroupOmega-3-acid Ethyl Esters | The Harvard Drug Group | Potency & Assay | Nationwide |
| Drug | CLASS II | Memantine Hydrochloride Extended-Release, Capsules, 7 mg recalledMemantine Hydrochloride | The Harvard Drug Group | Potency & Assay | Nationwide |
| Drug | CLASS II | Midodrine Hydrochloride Tablets, USP, 5 mg ( blister packs) recalledMidodrine Hydrochloride | The Harvard Drug Group | Packaging Defects | Nationwide |
| Drug | CLASS II | Gabapentin Capsules, USP, 100 mg ( blister packs) recalledGabapentin | The Harvard Drug Group | Potency & Assay | Nationwide |
Other Memantine recalls
All 7| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Drug | CLASS II | Memantine Hydrochloride Extended-Release, Capsules, 7 mg recalledMemantine Hydrochloride | The Harvard Drug Group | Potency & Assay | Nationwide |
| Drug | CLASS III | Memantine Hydrochloride Extended-Release Capsules recalledMemantine Hydrochloride | The Harvard Drug Group | Potency & Assay | 6 states |
| Drug | CLASS II | Memantine Hydrochloride Extended Release Capsules, 21 mg recalledMemantine Hydrochloride | Lupin Pharmaceuticals | Potency & Assay | Nationwide |
| Drug | CLASS III | Memantine Hydrochloride Extended-release Capsules, 28mg recalledMemantine Hydrochloride | Lupin Pharmaceuticals | Potency & Assay | Nationwide |
| Drug | CLASS II | Memantine Hydrochloride Oral Solution, 2 mg/mL recalled | Torrent Pharma | Sterility | Nationwide |